Methods and devices for percutaneously modifying organs to treat patients

ABSTRACT

Disclosed are methods and apparatus for implantation into the walls of an organ such as the stomach. Deformable or inflatable anchors with a connector between are used to pull the walls of the organ together, or to implant devices in the wall of the organ. Also disclosed are surgical instruments useful in practicing the disclosed methods.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 10/974,248 filed Oct. 27, 2004, which claims priority to U.S.Provisional Patent Application Ser. No. 60/556,004 filed Mar. 23, 2004by Michael Gertner, M.D., entitled “BARIATRIC DEVICES AND IMPLANTATIONMETHODS,” to U.S. Provisional Patent Application Ser. No. 60/584,219filed Jul. 1, 2004 by Michael Gertner, M.D., entitled “DEVICES ANDMETHODS FOR PERCUTANEOUS GASTROPLASTY,” and to U.S. Provisional PatentApplication Ser. No. 60/603,944 filed Aug. 23, 2004 by Michael Gertner,M.D., entitled “DEVICES AND METHODS TO TREAT MORBID OBESITY,” all ofwhich are herein incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods and apparatus for implantingdevices in the wall of a hollow organ, including devices to reduce thevolume of the stomach.

2. Description of the Related Art

Obesity is a public health problem of growing national and internationalimportance. There are an estimated 60 million obese adults and 2 millionobese adolescents in the United States as of 2004. By some estimates,there are 1 billion obese individuals worldwide.

Over the past four decades, there have been numerous surgical proceduresand devices developed to treat the morbidly obese. In general, there aretwo physiologic aspects of all past and current procedures:malabsorption and mechanical restriction/volume reduction.

Many of the procedures performed in the past have proven to beimpractical, dangerous, or detrimental to the health of the patients andare now of historical importance only. An example of a failed procedureis the jejunal-ileo bypass in which a malabsorptive state is createdthrough the bypass of a large portion of the intestine through thecreation of a surgical anastamosis between the jejunum and the ileum.While patients initially lost a great deal of weight, liver failure orliver damage occurred in over one-third of the patients whichnecessitated reversal of the surgical procedure.

The Roux-en-Y (The Roux) bypass operation has evolved to become the mostcommonly performed surgical procedure to treat the morbidly obese. Itcombines a small degree of malabsorption with a 90% reduction in thevolume of the stomach. In the United States, 150,000 procedures arepredicted for the year 2004. This number is expected to rise to 500,000procedures by 2006. The procedure has been performed since the late1970's and the long-term data has been very good. The advent oflaparoscopic surgery and hence the laparoscopic Roux-en-Y bypass incombination with excellent follow-up results from the open procedure arereasons for the proliferation of the Roux procedure.

Despite the efficacy of the Roux procedure and the recent laparoscopicimprovements, it remains a highly invasive procedure with substantialmorbidity including a 1-2% surgical mortality, a 20-30% incidence ofpulmonary morbidity such as pneumonia, pulmonary embolism, etc., and a1-4% chance of leak at the anastamotic site which can result in aspectrum of consequences including an extended hospital stay to death.

The Roux procedure requires general anesthesia and muscle paralysiswhich, in the morbidly obese population, is not of small consequence.There is also a substantial rate of anastamotic stricture which resultsin severe lifestyle changes for patients. For example, many patients areforced to vomit after meals.

The largest problem from the perspective of the patient is that theRoux-en-Y is not reversible, which dramatically limits the number ofpatients willing to undergo the procedure. In particular, it severelylimits the number of procedures which can or should be performed onadolescents.

The Magenstrasse and Mill (M&M) procedure is an evolving techniquewherein the greater curvature of the stomach is essentially taken out ofthe path of food, leaving a tube of stomach, the Magenstrasse, or streetof the stomach, comprised of the lesser curvature. The antrum ispreserved in this procedure. The theory behind leaving the antral “mill”is that it will continue to serve its normal function of mixing,grinding, retropulsion, and well-regulated expulsion of chyme into theduodenum. An authoritative study on the operation is incorporated hereinby reference (Johnston et. al. The Magenstrasse and Mill Operation forMorbid Obesity; Obesity Surgery 13, 10-16).

Percutaneous Endoscopic Gastrostomy (PEG) refers to a procedure in whicha gastrocutaneous tract is created using percutaneous means. A recentupdate of the procedure can be found on the Society of AmericanGastrointestinal Endoscopic Surgeons (SAGES) website, and isincorporated herein by reference. Briefly, the procedure involvesinsufflation of the stomach with and under visualization with anendoscope. A small incision is made in the skin and a needle is advancedinto the stomach (the stomach sits just under the abdominal wall wheninsufflated) under endoscopic visualization. A feeding tube is thenplaced over the needle to create a gastrocutaneous tract with thefeeding tube inside the tract. The feeding tube is secured with anexternal bolster. Over the ensuing weeks, a permanent tract evolvesbetween the stomach mucosa and epithelium of the skin, after which, thebolster can be removed without consequence. When the feeding tube is tobe removed, the gastrocutaneous tract will closet on its own as foodwill preferentially be delivered antegrade (the path of leastresistance) to the duodenum, thereby allowing the tract to heal.

Recently, minimally invasive procedures and devices which create afeeling of early satiety have been introduced into the marketplace. TheLAP-BAND™ is a band which encircles the stomach at the region of thefundus-cardia junction. It requires general anesthesia, apneumoperitoneum, muscle paralysis, and extensive dissection of thestomach at the level the gastroesophageal junction. Although lessinvasive than the Roux procedure and potentially reversible, theLAP-BAND™ is nonetheless quite invasive. It also does not reduce thevolume of the stomach and patients report a feeling of hunger much ofthe time.

More recently, there has been an effort to develop even less invasivedevices and procedures which do not involve incisions at all. For themost part, these procedures are performed from within the stomach withan endoscope and by a phyisician with a high degree of endoscopic skill.For example, U.S. Pat. No. 6,558,400 describes methods and devices tocreate partitions in the stomach. Fasteners or staplers applied throughan endoscope from within the stomach are used to accomplish thepartitions. Similarly, U.S. Patent Application Publication No.2004/0122456 describes another set of methods and devices to reduce thevolume of the stomach. Expandable anchors are deployed both on theanterior and posterior wall of the stomach by way of an endoscope.Flexible sutures are brought out of the patient's mouth and the suturesare crimped together within the stomach in order to bring the walls ofthe stomach closer together. Patent application WO2004/004542 describesa device which is advanced through an endoscope and grasps or appliessuction to a fold of mucosa to apply fasteners through the mucosal andserosal layers of the stomach.

Endoscopic procedures to manipulate the stomach are time consumingbecause of the technical difficulty of the endoscopy; they also requirea large endoscope through which many instruments need to be placed forthese complex procedures. Due to the large girth of the endoscope,patients typically will require general anesthesia, limiting the“non-invasive” aspects of the procedure. Furthermore, the proceduresrequire advanced endoscopic skill which would need to be acquired bymost practitioners. Such skill adaptation can take a significant amountof time, which will limit adoption of the procedure by the physiciancommunity. A further issue is that there is a limitation on the size ofthe anchors which can be placed because the endoscope has a maximumsize.

SUMMARY OF THE INVENTION

One embodiment of the present invention is a method for reducing theinterior volume of an organ comprising passing a first end of a firstsurgical instrument through the patient's skin, through a first exteriorsurface of the organ, through the interior of the organ, and thenthrough a second exterior surface of the organ, so that the surgicalinstrument traverses the organ, deploying a first anchor from thesurgical instrument wherein the first anchor is located adjacent to thesecond exterior surface of the organ, partially or completelywithdrawing the surgical instrument, deploying a second anchor whereinthe second anchor is located adjacent to the first exterior surface ofthe organ, providing a connector between the first and second anchors,wherein the length of the connector between the first and second anchorsis such that the first and second anchors urge the first and secondexterior surfaces of the organ toward each other, thereby reducing thevolume of the organ. In some embodiments, the first and second anchorsare deployed from the same surgical instrument. Another aspect of theinvention is a method of reversing the volume reducing procedure bycutting or otherwise dividing the one or more connectors between thefirst and second anchors. In another embodiment of the method, the organis a gastrointestinal organ. The method may further comprise creating aspace outside the organ adjacent to the second exterior surface thereofby introducing a volume-filling substance into a potential spaceadjoining the second exterior surface. The potential space can beexpanded by the injection of a gas, liquid, gel, foam, or solid, intothe potential space, by the inflation of a balloon placed in thepotential space, or by blunt dissection. The method may further compriseinsufflating the organ prior to the passing of the first end of asurgical instrument through a first exterior surface of the organ. Insome embodiments, the patient's skin is overlying the patient's stomach,the organ is the patient's stomach, the first exterior surface is theanterior wall of the stomach, the second exterior surface is theposterior wall of the stomach, and the potential space is the lesser sacof the peritoneum. The method may further comprise urging the anteriorand posterior walls of the stomach closer together by shortening thelength of the connector between the first and the second anchors. Insome embodiments, the surgical instrument is inserted into the patient'sabdomen by directly penetrating the patient's skin and abdominal wall,by passing the surgical instrument through a laparoscopic port, or bypassing the surgical instrument through an incision in the patient'sskin and abdominal wall

Another embodiment of the invention is a method for reducing the volumeof a patient's stomach, comprising passing a first anchor through apatient's abdominal skin, and through the patient's anterior andposterior stomach walls, wherein the first anchor is in a reducedprofile configuration, passing a second anchor through a patient'sabdominal skin and adjacent to the patient's anterior stomach wall,connecting the first and second anchors by means of a connector thatpasses through the stomach, urging the first and second anchors towardeach other, and holding the anterior and posterior walls of the stomachtogether with the first and second anchors, wherein the first anchor isin a deployed configuration and the connector prevents the first andsecond anchors from moving apart. Some embodiments further comprisepassing the second anchor through the patient's abdominal skin while thesecond anchor is in a reduced profile configuration, as well as thesecond anchor subsequently being in a deployed configuration. In someembodiments, the holding of the anterior and posterior walls of thestomach together is performed in a manner that permits some spacebetween mucosal surfaces of the stomach interior of the walls. In otherembodiments it is performed in a manner that permits contact betweenmucosal surfaces of the stomach interior of the walls. In someembodiments, the holding step is performed by adjusting the relativeposition of the connector and the second anchor, and then configuringthe second anchor to engage the connector in a manner that prevents thefirst and second anchors from moving apart.

Another embodiment of the invention is a fastening assembly, comprisinga first anchor, a second anchor, and a connector, wherein the firstanchor comprises a relatively planar body attached to the connector, thebody of the first anchor having a relatively planar deployed profile anda reduced profile configuration, wherein the second anchor comprises arelatively planar body, a hole or other passageway approximately in thecenter of the body of sufficient diameter to allow passage of theconnector through the hole or other passageway, one, two or moregripping elements projecting into the hole or other passageway, and one,two or more attachment structures accessible from a top surface of thebody, the body of the second anchor having a relatively planar deployedprofile and a reduced profile configuration, and wherein the grippingelements prevent movement of the second anchor along the longitudinalaxis of the connector in the direction away from the first anchor whenthe connector is disposed in the hole or other passageway when thesecond anchor is in its deployed configuration.

Another embodiment of the invention is a biocompatible surgical anchoradapted for use in connecting the walls of a hollow organ or anchoring adevice to the wall of a hollow organ, comprising a body portion, whereinthe body portion is compressible and can assume a relatively planardeployed configuration and a reduced-profile compressed configuration,wherein the body portion has an opening extending therethrough, and agripper on the body portion adapted to grip an elongated connector assuch a connector extends through the opening, wherein the gripperengages such a connector when the anchor is in the deployedconfiguration, and releases such a connector when the anchor is in thecompressed configuration. In some embodiments, the body portion isinflatable and can assume a relatively planar deployed configurationwhen inflated and a reduced-profile configuration when uninflated,wherein the body portion has an opening extending therethrough, and agripper on the body portion adapted to grip an elongated connector assuch a connector extends through the opening, wherein the gripperengages such a connector when the anchor is inflated, and releases sucha connector when the anchor is uninflated.

Another embodiment of the invention is a fastening assembly, comprisinga first anchor, a second anchor, and a connector, wherein the firstanchor comprises an inflatable body attached to the connector, the bodyof the first anchor having a deployed configuration when inflated thatis relatively spherical and a reduced profile configuration whenuninflated wherein it is readily deformable, wherein the connector ishollow and configured to allow inflation of the first anchor by deliveryof a filling substance through the connector to the first anchor.

Another embodiment of the invention is a method of fastening a device toone wall of a gastrointestinal organ comprising passing said devicethrough a patient's abdominal skin, and through the patient's anteriorstomach wall, wherein the device is in an undeployed configuration,passing an anchor through a patient's abdominal skin wherein the anchoris in an undeployed configuration, connecting the device and the anchorby means of a connector that passes through the wall of thegastrointestinal organ wherein the connector prevents the device andsecond anchor from moving apart, and deploying the anchor to itsdeployed configuration. In another embodiment, the device comprises aninflatable body attached to the connector, the body of the device havinga deployed configuration when inflated that is relatively spherical anda reduced profile configuration when uninflated wherein it is readilydeformable, wherein the connector is hollow and configured to allowinflation of the device by delivery of a filling substance through theconnector to the device.

In another embodiment, the device is an electrical stimulator.

In yet another embodiment, the device is adapted to deliver a medicine.

In any of the embodiments, the reduced profile configuration can besubstantially compressed and/or uninflated in the undeployedconfiguration, or inflated and/or uncompressed, in the deployedconfiguration.

In any of the embodiments, it can be the case that the gripping elementsdo not prevent movement of the second anchor along the longitudinal axisin either direction when the connector is disposed in the hole or otherpassageway when the second anchor is in its reduced profileconfiguration.

In any of the embodiments it may be the case that the gripper orgripping elements, when engaging a connector, allow movement of theconnector in one direction relative to the anchor but prevents movementof the connector in an opposite direction relative to the anchor.

In any of the embodiments, the body of the first anchor can beinflatable, have a relatively planar deployed profile when inflated anda reduced profile configuration when uninflated, be readily deformablewhen uninflated, and the connector can be hollow and configured to allowinflation of the first anchor by delivery of a filling substance throughthe connector to the first anchor.

In any of the embodiments, the body of the second anchor can beinflatable, wherein the second anchor has a relatively planar deployedprofile when inflated and a reduced profile configuration whenuninflated, and wherein the second anchor is readily deformable whenuninflated.

In any of the embodiments it may be the case that the anchor has aninflation tube connected to the body portion configured to allowinflation of the body portion by delivery of a filling substance throughthe inflation tube to the body portion.

In any of the embodiments, it can be the case that the filling substancehardens, cures, polymerizes, or become a gel over time, and isoptionally bioabsorbable with further time.

In any of the embodiments, it can be the case that the second anchor hasone or more attachment structures accessible from a top surface of thebody.

In any of the embodiments, the first anchor, the second anchor, or boththe first and the second anchors, can deliver an electrical signal totissue when placed in contact with the tissue. In some embodiments, onlythe first or second anchor is placed which then delivers an electricalsignal.

Another embodiment of the invention is a surgical instrument comprisinga proximal end, a distal end, and a shaft with a channel, the distal endcomprising a tissue penetrator adapted to penetrate, cut, or dilate thewall of a hollow organ, and a tissue grasper adapted to grasp a wall ofa hollow organ, an expander within the channel of the surgicalinstrument wherein the expander can be deployed from within the channelof the instrument and extend through a wall of the hollow organ whilethe wall is being grasped by the tissue grasper, and is adapted tointroduce a volume-filling material or device beyond the hollow organ.

Another embodiment of the invention is a surgical instrument comprisinga proximal end, a distal end, and a channel, wherein the distal endcomprises a tip which has an open configuration and a closedconfiguration, wherein in the closed configuration, the tip is adaptedto penetrate a wall of a hollow organ, wherein in the openconfiguration, the tip can grasp the wall of the hollow organ, andwherein the channel comprises a diameter of about 2 mm to 12 mm.

Another embodiment of the invention is an anchor implantation instrumentcomprising, an outer sheath, a middle sleeve disposed within the outersheath, an inner member disposed within the middle sleeve, and a channelwithin the inner member, wherein the middle sleeve has an outer diameterand a longitudinal axis, and the outer diameter of the middle sleeve issuch that it can slide within the outer sheath along the longitudinalaxis of the middle sleeve, wherein the inner member has an outerdiameter, and the outer diameter of the inner member is such that it canslide within the middle sleeve along the longitudinal axis of the middlesleeve, wherein the inner member has a grasper suitable for grasping afoldable anchor and wherein the outer sheath has a distal portion whichhas an inner diameter sufficient to hold a foldable anchor in its foldedconfiguration.

BRIEF DESCRIPTION OF THE DRAWING

FIGS. 1A-1E are perspective views of embodiments of the posterior anchorand connector.

FIGS. 1F and 1G are side views of an inflatable embodiment of posterioranchor and connector.

FIGS. 2A and 2B are a perspective view and top view of one embodiment ofan anterior anchor, respectively.

FIGS. 2C and 2D are side sectional views of the embodiment of theanterior anchor of FIGS. 2A and 2B, taken along the line B-B in FIG. 2B,in its deployed and reduced profile configuration, respectively.

FIGS. 2E and 2F are side sectional views of another embodiment of ananterior anchor, taken along the same line as FIGS. 2C and 2D, in itsdeployed and reduced profile configuration, respectively.

FIGS. 2G is a perspective view of an inflatable embodiment of ananterior anchor.

FIGS. 2H and 2I are side sectional views of the embodiment of theanterior anchor of FIG. 2G, taken along the line D-D in FIG. 2G, in itsdeployed and reduced profile configuration, respectively.

FIG. 3A is a perspective view of another embodiment of an anterioranchor.

FIGS. 3B and 3C are perspective views of the embodiment of the anterioranchor shown in FIG. 3A in its reduced profile and deployedconfiguration, respectively.

FIG. 3D is a perspective view of another embodiment of an anterioranchor.

FIGS. 4A and 4A′ are a side and blow-up view, respectively, of oneembodiment of a tissue grasping instrument with the distal end in itsopen configuration.

FIGS. 4B and 4B′ are a perspective and blow-up view, respectively, ofthe tissue grasping instrument of FIG. 4A with the distal end in itsclosed configuration.

FIGS. 4C and 4C′ are a perspective and blow-up view, respectively, ofanother embodiment of the tissue grasping instrument with the distal endin its closed configuration.

FIG. 5A is a side view of one embodiment of an anchor implantationinstrument.

FIG. 5B is a perspective view of the distal end of the anchorimplantation instrument of FIG. 5A and an anterior anchor and connector.

FIG. 5C is a side sectional view of the distal end of the anchorimplantation instrument of FIGS. 5A and 5B, taken along line C-C in FIG.5B, with the anterior anchor in its reduced profile configuration.

FIG. 6A illustrates the first step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 4 inserted into thepatient's abdomen through a laparoscopic port.

FIG. 6B illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 4 grasping the posteriorwall of the stomach and a needle being inserted into the potential spaceof the lesser peritoneal sac.

FIG. 6C illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 4 grasping the posteriorwall of the stomach and a posterior anchor and connector deployed in theexpanded potential space of the lesser peritoneal sac.

FIG. 6D illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with a posterior anchor and connector deployed in theexpanded potential space of the lesser peritoneal sac, with theconnector passing out of the patient's abdomen through a laparoscopicport.

FIG. 7A illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 5C placing an anterioranchor in the patient's abdomen adjacent to the anterior wall of thestomach.

FIG. 7B illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with an anterior anchor in its deployed configurationon the connector, with the anterior and posterior walls of the stomachurged together.

FIG. 7C illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen after the connector has been cut flush with theanterior anchor.

FIG. 8A illustrates an embodiment of a method of reducing the volume ofthe stomach. Shown is a side sectional view of a patient's abdomen aftertwo posterior anchors and connectors have been deployed adjacent to theposterior wall of the stomach, with the connectors passing out of thepatient's abdomen through laparoscopic ports.

FIG. 8B shows the connectors of FIG. 8A with clamps placed on theconnectors outside the patient's body to temporarily hold the connectorsin a test position.

FIG. 9 is a perspective view showing three transgastric fasteningassemblies deployed in a patient's stomach.

FIG. 10A illustrates one embodiment of a method for deploying a volumedisplacing device in the stomach. Shown is a side sectional view of apatient's abdomen after an uninflated balloon anchor has been insertedinside the patient's stomach with a connector passing out of thestomach, through the anterior stomach wall, and a laparoscopic port.

FIG. 10B illustrates one embodiment of a method for deploying a volumedisplacing device in the stomach. Shown is a side sectional view of apatient's abdomen with the balloon anchor in its deployed position, heldin place by an anterior anchor.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Anatomy of the Stomach

The region behind the stomach is referred to as the lesser peritonealsac. It is a potential space between the retroperitoneum and theposterior wall of the stomach. To the left of the midline, the posteriorwall of the stomach is generally free from the peritoneal surface of theretroperitoneum. To the right of the midline, the posterior wall of thestomach is more adherent to the retroperitoneum although the adherenceis generally loose and the adhesions can be broken up rather easily withgentle dissection.

The stomach is comprised of several layers. The inner layer is themucosa. The next layer is the submucosa followed by the outer muscularlayers. Surrounding the muscular layers is the serosal layer. This layeris important with regard to implants and healing because it is theadhesive layer of the stomach; that is, it is the layer which, whenbreached, heals with scar tissue formation. Implants adhering to thislayer are less likely to migrate into the stomach. Reference to “stomachwall” or “wall of the stomach” as used herein include the entirethickness of the stomach, including the mucosa, submucosa, muscularlayers, and serosa. The “anterior wall of the stomach” is the portion ofthe stomach closest to the muscular abdominal wall and the “posteriorwall of the stomach” is the part of the stomach closest to theretroperitoneum.

“Transgastric fastening assembly” refers to a permanent orsemi-permanent implant and comprises at least one posterior anchor, atleast one anterior anchor, and a fastener to connect the posterior andanterior anchors. The “fastener” can refer to any means of connectionincluding but not limited to a material connection, an electromagneticconnection, or a chemical connection. As used herein, a “connector” is afastener used to materially connect anterior and posterior anchors. Asused herein, the “posterior anchor” is the anchor in a preferredembodiment which is adjacent to the posterior wall of the stomach whendeployed. The “anterior anchor” is the anchor in a preferred embodimentwhich is approximated to the anterior wall of the stomach when deployed.

As used herein when referring to portions of a surgical instrument,“proximal” refers to the end of the instrument which is closest to thesurgeon when the instrument is used for its intended purpose, and“distal” refers to the end of the instrument which is closest to thepatient when the instrument is used for its intended purpose. When usedto refer to the gastrointestinal tract, “proximal” is toward the mouthand “distal” is toward the anus.

Percutaneous surgery typically means that the procedure is performedunder visualization (e.g. fluoroscopic, MRI, CAT Scan, Ultrasound,Endoscopic) which is not direct visualization and which requires anincision, typically small, somewhere in the skin. More recently, theboundaries of percutaneous surgery have been blurred as some proceduresinvolve both direct visualization, such as with a laparoscope, andpercutaneous methodology. An example of such a procedure is thelaparoscopic placement of a jejunostomy or gastric feeding tube.Laparoscopic methods require general anesthesia to paralyze theabdominal muscles so that the abdomen can be filled with gas.Consequently, general anesthesia is required so as to enable paralysisof the diaphragm and respiratory muscles.

As used herein, “percutaneous” refers to a procedure wherein generalanesthesia and general pneumoperitoneum are not used or the procedureutilizes incisions through the skin of the abdomen for access to thesurgical site and not for visualization. Therefore, as used herein,percutaneous surgery and laparoscopic surgery are mutually exclusive. Inthe preferred embodiment, the methods described herein are performedpercutaneously, although laparoscopic methods are contemplated.

Structures

Transgastric Fastening Assembly

Referring to FIGS. 1A and 1B, one embodiment of the posterior anchor 14and connector 12 are shown in a deployed configuration (FIG. 1A), andreduced profile configuration (FIG. 1B). The connector 12 is preferablymade of a biocompatible semi-rigid polymer, but it can be made fromvarious kinds of suitable biocompatible materials known to those ofskill in the art including metals, such as titanium and platinum, metalalloys, such as stainless steel, nickel-titanium, and cobalt-chromium,man-made polymers, such as polyurethane, silicone elastomers,polyglycolic acid, polylactic acid, poly (c-caprolactone),polyvinylidene fluoride (PVDF), PTFE, polypropylene, or natural fiberssuch as silk. These materials can be used singly or in combination. Forexample, one portion of the connector may be bioabsorbable and anotherportion of the connector may be permanent. The connector 12 can vary inthickness, shape, and rigidity. For example, in the embodiment shown inFIG. 1A, the connector 12 is substantially rod-shaped, with a circularcross-section, and is semi-rigid. Those of skill in the art willrecognize that the cross-section of the connector can be any of a numberof shapes, such as square, hexagonal, oval, etc. In other embodiments,the connector 12 is thin and flexible, such as a surgical suture, and instill others it is rigid.

In a preferred embodiment, the posterior anchor 14 is made from abiocompatible, radio-opaque or magneto-opaque semi-rigid polymer; it canalso be made from various kinds of suitable materials known to those ofskill in the art including metals, metal alloys, plastics, naturalmaterials or combinations thereof as discussed above. The posterioranchor 14 can be solid, or alternatively, can be porous, mesh-like,lattice-like, or umbrella-like. In a preferred embodiment, the posterioranchor is porous or has a porous mesh attached to it to encouragefibrous ingrowth such that it becomes permanently attached to thestomach or intestinal wall. Coatings can be added to the anchor toencourage tissue ingrowth. In other embodiments, the posterior anchor issolid and treated to discourage tissue ingrowth. In other embodiments,the anterior anchor has a xenograft or allograft material attached tothe anchor. In a preferred embodiment, the posterior anchor 14 isdisc-shaped, but those of skill in the art will recognize that otherembodiments are possible, such as those shown in FIGS. 1C and 1D, ordisclosed in U.S. Patent Application Publication No. 2004/0122456 whichis herein incorporated by reference; note particularly the descriptionof anchor structures. The posterior anchor can also be bioabsorbable inwhole or in part in some embodiments.

In the embodiment shown in FIGS. 1A and 1B, the connector 12 is fastenedto the posterior anchor 14 at an attachment point 16 which is preferablya permanent, e.g. welded or molded, connection. Such a weld orconnection can comprise, for example, a thermoformed polymer, a metallicweld, or a molded or other integral structure. In a preferredembodiment, a biocompatible thermoformed polymer is used because of itsflexibility and ability to yield to the continuous motion of thestomach. More preferably, the connector and posterior anchor areproduced as a single, continuous injection molded component.

Other suitable means of fastening the connector to the posterior anchorare also contemplated and do not necessarily result in a connector andposterior anchor becoming permanently attached. For example, in oneembodiment shown in FIG. 1C, one end of the connector is passed througha hole 20 near the center of the posterior anchor 22, and a stop 24,such as a knot or enlarged molded region, is formed on the end of theconnector to prevent its passage back through the hole in the posterioranchor. In this embodiment, the posterior anchor 22 can be free to movealong the length of the connector 26, but is prevented from beingremoved from one end of the connector by the stop 24.

In the embodiment shown in FIGS. 1A and 1B, the posterior anchor 14preferably has a deployed configuration (FIG. 1A), and reduced profileconfiguration (FIG. 1B). The posterior anchor 14 can be deformed to afolded configuration wherein its profile is reduced to facilitateinsertion of the anchor through the walls of the stomach or other tissueas described in more detail below, In one embodiment, the posterioranchor 14 is made of a semi-flexible material having shape memory, sothat once the anchor is deployed within the patient, it will return toits original shape shown in FIG. 1A, preventing it from being easilypulled back through the tissue. Preferably, the posterior anchor isinflatable in place oft or in addition to, having shape memory, whichallows for a much larger deployed profile relative to its undeployedprofile. (See below).

FIGS. 1D and 1E show an alternative embodiment of the posterior anchor30 and connector 32 in a deployed configuration (FIG. 1D), and a reducedprofile configuration (FIG. 1E). In this embodiment, the posterioranchor 30 is elongated, having major and minor dimensions, andpreferably having a rod or bar shape. By aligning the connector 32substantially parallel to the posterior anchor 30, its profile isreduced to facilitate insertion of the anchor through the walls of thestomach or other tissue. When the anchor leaves its surrounding sheath(see below), tension on the connector 32 in the direction of the arrowin FIG. 1E will urge the posterior anchor 30 into a substantiallyperpendicular orientation relative to the connector 32, as shown in FIG.1D, preventing it from easily being pulled back through the tissue. Theconnection between the posterior anchor 30 and the connector 32 can behinged. Alternatively, the connector 32 can be made of a semi-rigidmaterial which is permanently connected or welded to the posterioranchor 30. If the connector is deformed to a bent position, shown inFIG. 1E, it will return to its original straight shape shown in FIG. 1Donce the anchor is deployed within the patient, preventing the posterioranchor from easily being pulled back through the tissue. This anchor 30can be inflatable as well, which allows for a much larger deployedprofile relative to its undeployed profile.

In a preferred embodiment, shown in FIGS. 1F and 1G, the posterioranchor is inflatable. The anchor has an inflatable disc-shaped body 34which is readily deformable when in its reduced profile (i.e.,uninflated) configuration as shown in FIG. 1F. In the preferredembodiment, the posterior anchor body 34 is disc-shaped, but those ofskill in the art will recognize that other embodiments are possible,such as those shown in FIGS. 1C and 1D, or in which the inflatableanchors are square shaped, rectangular, or amorphous, or have a shapedisclosed in U.S. Patent Application Publication No. 2004/0122456 whichis herein incorporated by reference; note particularly the descriptionof anchor structures. The body can be inflated with a substancedelivered through a hollow connector 35. When the interior space 36 ofthe anchor body is inflated, the anchor assumes its deployedconfiguration shown in FIG. 1G.

The inflatable posterior anchor can have a valve 38 located between theanchor body 34 and the connector 35. Alternatively, the valve is locatedin the portion of the connector located outside the patient, the valve(e.g. stopcock type valve) being controlled by the operator until theanterior anchor is placed (see below). In this alternative embodiment,the filling substance is trapped in the posterior anchor after theanterior anchor is deployed and the connector is cut and sealed,preferably flush with the anterior anchor (see below). The fillingsubstance can be a gas, liquid, or material which changes phase withtime (i.e. it may harden, cure, polymerize, or become a gel with time).Preferably, the surface of the posterior anchor adjacent to theposterior-wall of the stomach has a mesh fixed to it to encourage tissueingrowth. In some embodiments, part, or all of the anchor material iscomprised of a biodegradeable material.

FIGS. 2A (perspective view) and 2B (plan view) show an embodiment of theanterior anchor 40. The anterior anchor has a disc-shaped body 42 with ahole or other passageway 44 substantially in the middle of the body. Twogripping elements 46 project into the center of the hole or otherpassageway. With respect to the gripping elements, there can be as fewas one or more than two. The gripping elements may have teeth 50 angledtoward the top surface of the anchor. Optionally, two hooks 52, or othergraspable recesses, appendages, or structures, are located on the topsurface of the anterior anchor. Hooks 52 allow for attachment of asurgical instrument during deployment of the anterior anchor in thepatient as described below. Alternatively, there can be none, one, ormore than two graspable recesses, appendages, or structures on the topsurface of the anchor. In the preferred embodiment, the anterior anchorbody 42 is disc-shaped, but those of skill in the art will recognizethat other embodiments are possible, as disclosed in U.S. PatentApplication Publication No. 2004/0122456 which is herein incorporated byreference; note particularly the description of anchor structures.

FIGS. 2C and 2D are cross sections of the anterior anchor of FIGS. 2Aand 2B, taken along the line B-B in FIG. 2B. FIG. 2C shows the anterioranchor in its deployed configuration with the connector 12 of FIG. 1Apassing through the hole or other passageway 44 in the body of theanchor. In the deployed configuration, the gripping elements 46 andteeth 50 engage the connector 12 with sufficient pressure to preventmovement of the anchor along the connector 12 in the direction of thearrow in FIG. 2C, which would increase the distance between the anterioranchor and posterior anchor (not shown). In FIG. 2D, the anterior anchor40 is in its reduced profile configuration with the connector 12 of FIG.1A passing through the hole or other passageway 44 in the body of theanchor. Preferably, the anterior anchor is made of a semi-rigid polymerwhich allows the anchor to be deformed into a substantially foldedconfiguration illustrated in FIG. 2D. When in this configuration, thegripping elements 46 and teeth 50 do not significantly engage theconnector 12. This allows movement of the anterior anchor 40 along thelength of the connector 12 in the directions illustrated by the arrowsin FIG. 2D. Once the anterior anchor is in the desired position alongthe connector 12, the anterior anchor is permitted to return to theconfiguration shown in FIG. 2C, and the gripping elements 46 and teeth50 engage the connector 12, thus preventing movement between theconnector 12 and the anterior anchor 40.

In an alternative embodiment, it is contemplated that the connector 12can have notches 51, which interact with gripping elements 46 in aratchet-and-pawl mechanism similar to that used in cable ties, providinga one-way adjustability, in which the posterior and anterior anchors canbe moved toward each other, but not away from each other.

FIGS. 2E and 2F illustrate another embodiment of an anterior anchor 60which is similar to the one illustrated in FIGS. 2C and 2D. In FIG. 2E,the gripping elements 62 and teeth 64 are oriented so that the anterioranchor can be deformed such that the top surface of the anchor is foldedinward as illustrated in FIG. 2F. This is in contrast to the embodimentillustrated in FIG. 2D where the bottom surface of the anchor is foldedinward. The teeth 64 in FIG. 2E are angled toward the top surface of theanterior anchor and engage the connector 12 of FIG. 1A such that theyprevent movement of the anterior anchor along the connector 12 in thedirection of the arrow in FIG. 2E, which would increase the distancebetween the anterior anchor and posterior anchor (not shown).

FIG. 2G is a perspective view of a preferred embodiment where theanterior anchor is inflatable. The anterior anchor has a hollow,inflatable disc-shaped body 65 with a hole or other passageway 66substantially in the middle of the body. Two gripping elements 67project into the center of the hole or other passageway, although therecan be as few as one or more than two. The gripping elements can haveteeth 68 angled toward the top surface of the anchor. Alternatively, ina preferred embodiment, the gripping elements are in the form of a roughsurface rather than the protruding elements as shown in FIG. 2G. Such asurface, which may be a sandpaper-like surface, creates enough frictionto prevent movement in either direction along the connector. Optionally,two hooks 69 are located on the top surface of the anterior anchor.Hooks 69 facilitate grasping by a surgical instrument during deploymentof the anterior anchor in the patient as described below. Alternatively,rather than hooks, there can be one or more graspable protrusions on thebody. In yet another embodiment, there are no hooks or graspableprotrusions, and the body of the anchor is grasped directly tomanipulate the anchor. In another embodiment, protrusions 69 aremagnetic or otherwise sticky in nature to facilitate attachment to asurgical instrument.

An inflation tube 63 is used to inflate and deflate the anchor. Thisinflation tube may or may not have a valve. In one preferred embodiment,the anterior anchor is filled with gas or fluid through the inflationtube and the fluid is held inside the anchor through an external (e.g.stopcock) valve controlled by the operator. When the inflation tube iscut at the end of the procedure, the inflation line is crimped closedthereby locking the inflating substance inside the anchor.Alternatively, the shears used to cut the inflation line can be metaland an electrocautery current can be applied through the shears and tothe inflation line to weld it closed.

FIGS. 2H and 2I are cross sections of the anterior anchor of FIG. 2G,taken along the line D-D in FIG. 2G. The disc-shaped body 65 is readilydeformable when in its reduced profile (i.e., uninflated) configurationas shown in FIG. 21. The body can be inflated with a substance deliveredthrough the inflation tube 63. When anchor body is inflated, the anchorassumes its deployed (i.e. inflated) configuration as shown in FIG. 2Hwith the connector 12 of FIG. 1A passing through the hole 66 in the bodyof the anchor. In the deployed configuration, the gripping elements 67and teeth 68 engage the connector 12 with sufficient pressure to preventmovement of the anchor along the connector 12 in the direction of thearrow in FIG. 2H, which would increase the distance between the anterioranchor and posterior anchor (not shown). Alternatively, rather thandefined gripping elements and teeth, the surface of body which definesthe sides of the hole or other passageway 66 can be configured such thatwhen the anchor body is inflated, the sides of the hole or otherpassageway expand to substantially close off the hole or otherpassageway and limit movement of the anchor relative to the connectorthrough friction between the connector and the anchor.

In FIG. 2I, the anterior anchor 65 is in its reduced profile (i.e.uninflated) configuration with the connector 12 of FIG. 1A passingthrough the hole 66 in the body of the anchor. When in thisconfiguration, the anchor body is readily deformable and the grippingelements 67 and teeth 68 do not significantly engage the connector 12.This allows movement of the anterior anchor 65 along the length of theconnector 12 in the directions illustrated by the arrows in FIG. 2I.Once the anterior anchor is in the desired position along the connector12, the anterior anchor is inflated by a filling substance deliveredthrough the inflation tube 63, and the anchor assumes its deployed (i.e.inflated) configuration as shown in FIG. 2H; the gripping elements 67and teeth 68 engage the connector 12, thus restricting movement of theanterior anchor 65 in one or both directions along the length of theconnector 12. The filling substance can be a gas, liquid, or materialwhich changes phase with time (i.e. it may harden, cure, polymerize, orbecome a gel with time).

FIG. 3A illustrates another embodiment of an anterior anchor 70consisting of two parts, an anchor body 72 and a readily deformablecollar 74. The anchor body and collar have a central hole or otherpassageway (76 and 78 respectively) through which the connector canpass. Preferably, the anterior anchor body is made of a semi-rigidpolymer which can be deformed into a folded configuration with a reducedprofile as illustrated in FIG. 3B. Preferably, the readily deformablecollar 74 is permanently deformable; i.e., once deformed, it does notreturn to its original shape. As illustrated by the arrow in FIG. 3B,both the collar 74 and anchor body 72 can move along the connector 12 ofFIG. 1A. Once the anchor body 72 is in the desired position, the collar74 is crushed, such that the collar 74 engages the connector 12 and canno longer move along the length of the connector 12. This prevents theanchor body 72 from moving along the length of the connector 12 in thedirection of the arrow illustrated in FIG. 3C, which would increase thedistance between the anterior anchor and posterior anchor (not shown).FIG. 3D illustrates an alternative embodiment of the anterior anchor 80,where the anchor body 82 and deformable collar 84 are a single piece.

In a preferred embodiment, the anterior anchor is made from abiocompatible, radio- or magneto-opaque polymer, but it can be made fromvarious kinds of suitable materials known to those of skill in the artincluding metals, metal alloys, plastics, natural materials orcombinations thereof as disclosed above, The anterior anchor can besolid, or alternatively, can be porous, mesh-like, umbrella-like orlattice-like. In a preferred embodiment, the anterior anchor is porous,mesh-like, umbrella-like or lattice-like to encourage fibrous ingrowthsuch that it becomes permanently attached to the stomach wall. Coatingscan be added to the anchor, or a mesh material such as polypropylene canbe fixed to the anchor surface, such that it touches the anteriorstomach wall and encourages tissue ingrowth. In other embodiments, theanterior anchor is solid and treated to discourage tissue ingrowth. Inother embodiments, the anterior anchor has a xenograft or allograftmaterial attached to the anchor. In a preferred embodiment, the anterioranchor is disc-shaped and substantially flat, but those of skill in theart will recognize that other embodiments are possible.

Surgical Instruments

FIG. 4A illustrates one embodiment of a tissue grasping instrument 200.The tissue grasper has a tubular outer sleeve 210 to which a portion ofa handle 212 is attached at the proximal end. As shown in more detail inthe blow-up, FIG. 4A′, disposed within the outer sleeve 210 is a tubularinner member 214 which has an outer diameter such that it can slidewithin the outer sleeve 210 in the longitudinal axis of the outer sleeve210 but cannot move substantially transverse to the longitudinal axis ofthe outer sleeve 210. At the proximal end of the inner member, a secondportion of a handle 216 is attached. At the distal end of the innermember is a pair of jaws 220 which is connected to the inner member at ahinge point 222. When the distal end of the inner member 214 isdisplaced from the inside of the outer sleeve 210 such that the hingepoint 222 is outside the outer sleeve, the jaws 220 assume their openposition as depicted in FIG. 4A. As the hinge point 222 is withdrawninto the outer sleeve 210, the outer sleeve forces the jaws 220 intotheir closed position, as illustrated in FIG. 4B. The opening andclosing of the jaws 220 can be accomplished by manipulation of thehandle portions 212 and 216.

The distal end of the grasping instrument 200 is configured to cut,puncture, or dilate tissue when the jaws 220 are in the closed position.In one embodiment shown in FIG. 4B, the jaws 220 havescrew-thread-shaped protrusions 224 on the surface. By rotating theinstrument as it passes through tissue, the protrusions 224 facilitatethe penetration of tissue, similar to a corkscrew. In another embodimentillustrated in FIG, 4C, the instrument has jaws 226 that form a sharptip 228 when closed. In yet another embodiment, the jaws form a bladewhich can cut through tissues when in the closed position. One of skillin the art would recognize that the above configurations can becombined, or that other configurations are possible which facilitate thepassage of the tip of the instrument through the wall of the stomach orother tissue.

It also should be realized to one skilled in the art that the closed endof the grasping device does not have to be the only instrumentresponsible for cutting through the tissue; the central lumen 230 of thedevice can be utilized to assist in tissue penetration. For example, aneedle (e.g. a Verres needle) 232 can be passed through the lumen andthe needle 232 can make the initial puncture through the tissue. Theconfiguration of the distal end of the grasper is meant to be a tissue,dilator and facilitator of the entry into the stomach after the needlemakes the initial puncture. For safety, the needle can be retracted asthe tissue grasper dilates the tissue.

In the embodiment of the tissue grasper 200 illustrated in FIG. 4A, theinner member 214 and outer sleeve 210 have a central tunnel 230 thatextends the length of the tissue grasper. The tunnel 230 allows for thepassage of an expanding means such as a needle 232, or other instrumentor device such as the posterior or anterior anchor described above,through the length of the tissue grasper as shown in FIG. 4A. Thecentral tunnel is also adapted such that a radially dilating sheath canbe inserted through it. The diameter of the central lumen is preferablyat least 4 mm, but can be at least 5, 6, 7, 8, 9, 10, 11, or 12 mm. Inan alternative embodiment, the distal jaws can be configured to closethrough an electromechanical means or purely magnetic means such thatthe inner member is not necessary.

FIG. 5A illustrates one embodiment of an anchor implantation instrument250. The implantation instrument has a tubular outer sheath 252 whichhas a handle 254 attached. At the distal end, the outer sheath flairsout to an increased diameter 255 to accommodate the anterior anchor inits substantially folded position as illustrated in FIG. 5C. Within theouter sheath is an anchor grasping instrument 256 similar to the tissuegrasping instrument of FIG. 4A, made up of a tubular middle sleeve 260and a tubular inner member 264. The tubular middle sleeve 260 has anouter diameter such that it can slide within the outer sheath 252 in thelongitudinal axis of the outer sheath 252 but cannot move substantiallytransverse to the longitudinal axis of the outer sheath 252.

The tubular middle sleeve 260 of the anchor grasping instrument has aportion of a handle 262 attached at the proximal end 261 of theinstrument. Disposed within the middle sleeve 260 is a tubular innermember 264 which has an outer diameter such that it can slide within themiddle sleeve 260 in the direction of the longitudinal axis of themiddle sleeve 260 but cannot move substantially in transverse to thelongitudinal axis of the middle sleeve 260. At the proximal end of theinner member, a second portion of a handle 266 is attached.

The distal tip 263 of the instrument is illustrated in more detail inFIGS. 5B and 5C, with the inclusion of the anterior anchor 40 of FIG. 2Aand connector 12 of FIG. 1A. FIG. SC is a side section view taken alongthe line C-C of FIG. 5B. At the distal end 263 of the inner member 264is a pair of hooking members 270 which are connected to the inner memberat a hinge point 272. When the distal end of the inner member 264 isdisplaced from the inside of the middle sleeve 260 such that the hingepoint 272 is outside the middle sleeve, the hooking members 270 assumetheir open position as depicted in FIG. 5B. As the hinge point 272 iswithdrawn into the middle sleeve 260, the middle sleeve forces thehooking members 270 into a closed position, as illustrated in FIG. SC.The opening and closing of the hooking members 270 can be accomplishedby manipulation of the handle portions 262 and 266.

The instrument is designed such that the anterior anchor is easilymanipulated. When the anterior anchor is in its substantially folded orcompressed configuration as in FIG. 5C, the entire anterior fastenerassembly can be manipulated along the longitudinal axis of the connector12. FIG. 5C depicts the assembly as it would be introduced over theconnector 12 and into the patient. The operator pulls the connector 12toward the operator such that the posterior anchor is urged toward theanterior anchor. When in position, the operator deploys anterior anchor40. To deploy anterior anchor 40, outer sheath 252 is pulled back towardthe operator. Middle sleeve 260 is then withdrawn proximally toward theoperator as well. Hooking members 270 tend to fan out as the middlesleeve is pulled back and will release hooks 52. Once deployed, anteriorfastener 40 is now fixed in a longitudinal position along the connector12.

If the surgeon wants to readjust the anterior anchor, connector 12 ismanipulated so that the hooks 52 of the anterior anchor are brought intocontact with hooking members 270; middle sleeve 260 is advanced distallyfrom the operator, permitting hooking members 270 to engage the hooks52; such contact is facilitated by pulling back (proximally) on theconnector 12. By manipulating the middle sleeve 260 over the hookingmembers 270, the hooks 274 on the ends of the hooking members 270 canengage the hooks 52 on the anterior anchor 40. The outer sheath 252 isthen slid over the anterior anchor 40 (or the anchor-middle sleevecomplex is withdrawn into the outer sheath 252), until it is compressedinto an undeployed configuration as shown in FIG..5C. As describedabove, when the anterior anchor 40 is in a substantially compressedconfiguration, it can move along the length of the connector 12 ineither direction.

In an embodiment where an inflatable anterior anchor such as the oneillustrated in FIGS. 2G-2I is utilized, a standard laparoscopic graspinginstrument (with teeth) can be used to manipulate the anterior anchor.When the inflatable anterior anchor is in the uninflated position, it issufficiently compliant such that it can easily be passed through alaparoscopic port prior to inflation and deployment or after it has beendeflated for readjustment; the middle sheath may not be necessarybecause the compliance of the balloon enables easy compression into theouter sheath The inflation tube 63 passes through the laparoscopic portand out of the patient. This allows the inflation tube 63 of the anchorto be temporarily opened or closed outside the patient allowing fordeflation and reinflation until the anchor is in place. The inflationtube is then sealed and cut off, preferably substantially flush to thesurface of the anterior anchor.

Methods

Implantation of the Transgastric Fastening Assembly

FIG. 6A depicts the initial step of a preferred embodiment of a surgicalmethod to implant the transgastric fastening assembly. The first part ofthe procedure involves entering the stomach with an endoscope 300 andinsulating the stomach with a gas. When insufflated, the anterior wallof the stomach 302 is pushed toward the anterior abdominal wall 304 tocreate a potential space. After insufflation of the stomach, an incisionis made in the skin and a standard laparoscopic port 306 is placedthrough the anterior abdominal wall 304 to a position wherein the distalend is in the potential space between the abdominal wall 304 and theanterior wall of stomach 302. The laparoscopic port can be a radiallydilating type port or similar port known in the art.

A particularly advantageous port is one which allows visualization ofthe individual abdominal layers as it is being pushed through theabdominal wall (well known to those skilled in the art). Use of such aport allows the surgeon to “see” the different layers of the abdominalwall from within the trocar (using a standard laparoscopic camera) asthe trocar is advanced through the abdominal wall. The endoscopic lightinside the stomach will be “seen” by the surgeon as the port approachesthe inner layers of the abdominal wall because the endoscopic lightsource transilluminates through the layers of the stomach wall and innerlayers of the abdominal wall. Such visualization is advantageous if thepatient has a very thick abdominal wall (e.g. in a morbidly obesepatient) because the surgeon needs to ensure that another organ (e.g.the colon) is not draped between the stomach and the posterior wall ofthe abdomen.

The tissue grasping instrument 200 of FIG. 4A is inserted through theport 306 with the jaws 220 in the closed position (with or without aneedle projecting in front of the instrument) and is passed through theanterior wall of the stomach 302. When the jaws of the instrument areclosed, the jaws define a sharp, dilating, and/or cutting configurationwhich can more easily advance through the stomach wall.

FIG. 6B depicts the next step in a preferred method. The jaws ofinstrument 200 are used to grasp the posterior wall of the stomach 314.The posterior wall of the stomach 314 is lifted away from theretroperitoneum 316, allowing for access to the potential space of thelesser peritoneal sac 320. A needle 232, such as a Veress needle(well-known in the art, a Veress needle allows for easy and safe accessinto and between two serosal layers), is inserted through the centralchannel 230 of the instrument and passed through the posterior wall ofthe stomach 314 into the potential space of the lesser peritoneal sac320. The potential space of the lesser peritoneal sac 320 is expanded byinjection of a gas, such as carbon dioxide, through the needle 232. Inother embodiments, the potential space is expanded using a liquid, gel,or foam. Alternatively, the space can be expanded using a balloon orother space expanding or space filling device; alternatively, a surgicalinstrument (e.g. electrocautery and/or blunt ended grasper, etc.) can beused in place of a needle to access the lesser peritoneum or to expandthe potential space of the retroperitoneum 320. Preferably, the expandedspace of the lesser peritoneal sac can extend from the angle of His atthe gastroesophageal junction to the pylorus.

In an alternative embodiment, the space is not expanded before theposterior anchor is placed. For example, in an embodiment where aninflatable posterior anchor is used, the potential space can be expandedby the anchor itself as it is inflated to its deployed configuration.

FIG. 6C depicts the next step in a preferred embodiment. With a directpath from outside the patient to the lesser peritoneal sac 322, theneedle 232 is withdrawn from the instrument 200. An optional dilationstep can be performed at this stage in the procedure using a device suchas a radially dilating sheath (e.g. InnerDyne STEP™ system; Sunnyvale,Calif.) inserted through the central channel 230 of the instrument. Thedilating device expands the opening in the posterior wall of the stomachin such a way that the opening contracts down to a lesser profile afterdilation. A posterior anchor 324 and connector 326, such as thosedepicted in FIGS. 1B, 1E or preferably 1F, in its reduced profileconfiguration, is passed through the central channel 230 of theinstrument, through the posterior wall of the stomach 314, and deployedin the lesser peritoneal sac 322 as shown in FIG. 6C. Where the optionaldilation step is performed, the posterior anchor 324 is passed throughthe dilating sheath. The connector 326 is preferably of sufficientlength to pass from inside the lesser peritoneal sac 322 through thecentral channel 230 of the instrument and out of the patient's body.FIG. 6D depicts the deployed posterior anchor 324 and connector 326after the grasping instrument is withdrawn from the patient and tensionis applied to connector 326 to pull the posterior anchor 324 against theposterior wall of the stomach 314.

FIG. 7A illustrates the next step in the embodiment. The connector 326is inserted through the hole or other passageway in an anterior anchor40 of FIG. 5C, and the anchor implantation instrument 250 of FIGS. 5A,5B and SC is used to slide the anchor 40 through the laparoscopic port306 into the abdomen of the patient. The anterior 302 and posterior 314walls of the stomach are urged together, either by using the anchorimplantation instrument 250 to urge the anterior wall 302 toward theposterior wall 314, or by pulling on the connector 326 and posterioranchor 324 to urge the posterior wall 302 of the stomach toward theanterior wall 314, or by a combination of the two methods. Once theanterior anchor 40 is in the desired position, the anterior anchor 40 isplaced in its deployed configuration by manipulating the anchorimplantation instrument 250 as described above.

In a preferred embodiment, the inflatable anterior anchor of FIGS. 2G-2Iis used, and the use of the implantation instrument of FIG. 5C isoptional. After the anterior anchor is in the desired position, theanterior anchor is inflated with a filling substance through theinflation tube until it is in its deployed configuration. The grippingelements 67 and teeth 68 are thus engaged against the connector 326. Theanchor implantation device 250 can then be withdrawn from the patient'sabdomen.

With the transgastric fastening assembly complete, the surgeon canexamine the resulting configuration of the stomach using an endoscope.If the anterior anchor is not in the desired location, its placementalong the connector can be adjusted as described above. Alternatively,in another embodiment, the anterior anchor can be urged closer to theposterior anchor simply by pushing it along the connector without usingthe implantation device to capture the anchor and deform it into itsreduced profile configuration.

In the preferred embodiment, the anterior anchor can be deflated,allowing the anterior anchor to be repositioned, and then reinflated toengage the connector. FIG. 7B illustrates the transgastric fasteningassembly with the anterior anchor 40 in its deployed configuration onthe connector 326 and the anchor implantation instrument removed fromthe patient's abdomen. The anterior 302 and posterior walls 314 of thestomach have been urged closer together by the transgastric fasteningassembly. Whether the walls of the stomach are urged into contact or notis determined by the surgeon.

FIG. 7C depicts the tiansgastric fastening assembly in its finalconfiguration after deployment. Once the surgeon is satisfied that thetransgastric fastening assembly is properly placed, a cutting implement,well-known to those of skill in the art, is inserted through thelaparoscopic port and the connector 326 is cut, preferably flush to theanterior anchor 40. In the preferred embodiment, where inflatableanchors are used, the hollow connector and inflation tube are sealedprior to, or as a result of, cutting, preventing anchor deflation.Alternatively, if a filling substance which hardens with time is used,it may not be necessary to seal the connector or inflation tube prior tocutting if the filling substance is sufficiently hard or viscous suchthat it will not leak from the connector or inflation tube.

When more than one transgastric fastening assembly is to be implanted,it is preferred to insert all of the posterior anchors and connectorsbefore attaching any anterior anchors, This is in contrast to attemptingto place one complete transgastric fastening assembly and thensubsequent assemblies. While possible, if one were to place entirefastening assemblies in series, each successive assembly would be moredifficult to place because the volume of the stomach would beprogressively reduced resulting in more difficult visualization eachtime.

FIG. 8A depicts an embodiment in which two posterior anchors 330 andconnectors 332 are deployed in the expanded lesser peritoneal sac. Inthis embodiment, there is one laparoscopic port 334 for each connector332. Alternatively, there may be more fasteners placed than incisionsand laparoscopic ports. Depending on how far apart the fasteners areplaced, a given laparoscopic port can be used to implant a plurality oftransgastric implants. This can be accomplished because there issignificant mobility of the stomach and/or abdominal wall which allowsfor different points along the anterior wall of the stomach to beaccessed without having to create another hole through the abdominalwall.

When it is desired to place more than one set of transgastric assembliesand in particular when the assemblies are placed concurrently ratherthan sequentially, the surgeon is afforded the opportunity to test (e.gmeasuring stomach volume, resistance to flow, assessing mucosalintegrity, etc.) varying tensions on one or more of the fasteningassemblies, all under endoscopic inspection. After the desired number ofposterior anchors and connectors are deployed in the patient, theconfiguration of the stomach can be tested by applying tension to theconnectors. FIG. 8B depicts temporary clamps 336 which sit on top of theports 334. Connectors 332 can be pulled from outside the abdomen to urgethe posterior wall of the stomach 340 toward the anterior abdominal wall342. One or more clamps 336 can then be closed to hold the stomach in atest position. To determine if the posterior anchors 330 are in thedesired location, an endoscope 344 can be used to view the configurationand the tension that the stomach will endure after the anterior anchorsare placed.

In an alternative embodiment, the stomach is fastened to the abdominalwall rather than there being a free space between the anterior gastricwall and the peritoneum of the abdominal wall. The initial steps are asdiscussed above. After the posterior anchors are placed, their positioncan be tested as depicted in FIG. 8B to simulate the configuration afterthe anterior fastener is placed. Next, the outer laparoscopic port ispulled back so that the anchor deploying instrument directly contactsand sits within the tissues of the muscular abdominal wall. Once theouter laparoscopic port is pulled back, the anterior anchor can bedeployed within the abdominal wall musculature and the connector can becut flush with the anterior fastener. In an embodiment where theinflatable anterior anchor is used, after the anterior anchor isdeployed within the abdominal wall musculature, the inflation tube iscut, preferably flush with the anterior anchor.

Reversal of the Gastric Volume Reduction Procedure

The connector of a preferred embodiment of the deployed transgastricfastening assembly, as illustrated in FIG. 7C, can be cut at a pointbetween the anterior and posterior anchors, which results in reversal ofthe gastric volume reduction. The connector is preferably made to resistcorrosion from stomach acid, but is able to be cut by a cuttingimplement advanced through an endoscope into the stomach. Materialssuitable to prevent corrosion and yet allow cutting include plasticssuch as polyurethane, silicone elastomer, polypropylene, PTFE, PVDF, orpolyester, metals and metal alloys such as stainless steel,nickel-titanium, titanium, cobalt-chromium, etc. Once the connector iscut, the walls of the stomach are free to move away from one another,thereby reversing the procedure. Reversal of the procedure can occur atany time (days to years) after the procedure. In a preferred embodiment,the anchors remain in the gastric wall permanently even after theconnector is cut or otherwise divided. Alternatively, the anchors can inpart or in whole be manufactured from a bioabsorbable material such thatthe anchors will eventually be absorbed by the body. In the case ofbioabsorbable anchors, it is preferable to have a connector which is atleast in part bioabsorbable. In another embodiment, substantially all ofthe elements of the transgastric fastening assembly are made ofbioabsorbable materials, with the intent that over the desired period oftime, the entire assembly will be absorbed by the body, reversing theprocedure without any additional actions required by a doctor.

Even if there is some degree of fusion between the mucosa around theconnector at the region of the assembly, once the connector is cut orabsorbed, the walls will tend to move apart over time. Alternatively, aballoon or other dissection device is introduced through an endoscopeand used to separate the walls of the stomach at the point of fusion.

Treatment of Disease Conditions

The devices, methods and instruments disclosed above can be used totreat obesity and other diseases involving the gastrointestinal tract,such as gastroesophageal reflux disease (GERD). FIG. 9 depicts threetransgastric fastening assemblies 400 deployed in the stomach. Thedashed lines represent boundaries of the divisions of the stomach: thecardia of the stomach 402, the fundus of the stomach 404, the body ofthe stomach 406, the antrum of the stomach 408, and the pyloricsphincter 410. In a preferred embodiment, the fastening assemblies arenot implanted in the antrum 408 in order to maintain the normaldigestion process of the stomach. Normal digestion occurs in the antrumwhich precedes passage of food into the duodenum. In stopping short ofthe antrum 408, the implants replicate the degree of volume reduction ofthe M&M procedure.

Food ingested by the patient follows a physiologic pathway for digestiondepicted by the arrow in FIG. 9. It travels through the esophagus 412and enters the cardia of the stomach 402. The food is digested in thestomach and pushed toward the duodenum 414 as chyme for furtherdigestion. The preserved antrum 408 will allow for relativelyphysiologic digestion and emptying into the duodenum 414 akin to the M&Mprocedure. With transgastric fastening assemblies 400 in place, foodwhich leaves the esophagus 412 and enters the stomach, results inincreased wall tension on the lesser curvature of the stomach 416 as thegreater curvature of the stomach 418 will be restricted from the foodpathway. The path of least resistance will be the path toward thepylorus 410 and duodenum 414. The increased wall tension of the stomachwill result in a feeling of satiety in the patient, leading to decreasedfood intake and weight loss. Although three assemblies are shown in FIG.9, there may be as few as one or as many as ten depending on the degreeof volume reduction desired. Such flexibility in number of devices aswell as the ability of the surgeon to tune the tension between theanterior and posterior fasteners is advantageous. Such flexibility mayenable, for example, reversal of a few fasteners rather than all thefasteners, such that the volume reduction procedure is partiallyreversed.

In another embodiment, a transgastric fastening assembly is placed inthe antrum 408 or the region just proximal to the pyloric sphincter 410if deemed necessary by the gastroenterologist and/or surgeon. Such aconfiguration would not reduce the volume of the stomach but would causea feeling of fullness similar to a gastric outlet obstruction, leadingto decreased food intake and weight loss. The fasteners in this regioncan also conduct a current to electrically stimulate the stomach tosimulate satiety.

In another embodiment, a transgastric fastening assembly may be requiredat the region of the cardia 402 to treat morbid obesity in a similarmanner to that utilized with the LAP-BAND™. In this embodiment, thetransgastric fastening assembly is not utilized to reduce the volume ofthe stomach, but to create a restriction to the inflow of food.

In another embodiment, the surgeon or gastroenterologist may choose totreat a disease such as gastroesophageal reflux disease (GERD) with atransgastric fastening assembly in the cardia region. Such aconfiguration would maintain the position of the GE junction in theabdomen and potentially great a barrier resistance to reflux contents.

In another embodiment, the disclosed method in combination with thetransgastric fastening assemblies can be adapted to attach agastrointestinal organ to the abdominal wall which in addition toreducing volume can also create a kink in the organ. The kink wouldcause a resistance barrier (in addition to volume reduction) togastrointestinal contents, and can be useful to treat reflux disease ormorbid obesity.

Such a kink would also fix the gastrointestinal region to the abdominalwall can also maintain the reduction of a hiatal hernia in the abdominalcompartment (e.g. in reflux disease). A major component of refluxdisease is a hiatal hernia in which the gastroesophageal junction freelyslides from the abdomen to the mediastinum. A percutaneously placedsuture or anchor in the region of the gastric cardia and/or fundus cantether the junction to the abdominal wall and confine the junction tothe abdomen.

In other embodiments, the devices and methods of this invention canassist in the implantation of devices such as stents, meshes, stitches,or tubes in the gastrointestinal tract. The major technical difficultyencountered in placing stents, tubes, and meshes inside the lumen of thegastrointestinal tract is that they tend to migrate because the walls ofsuch devices do not adhere to slippery mucosa. A transgastric ortransintestinal fastener, implanted with the current instrumentationwould solve this problem. Such a method would be particularly useful inthe attachment of the stent part of the stent-sleeve system outlined inpatent application WO 04049982, or the mesh of patent applicationWO03086247A1. In another example, devices such as those disclosed inpatent U.S. Pat. No. 6,773,441 attempt to place an endoscopic stitch totether the cardia of the stomach to the fundus to treat reflux disease.Such stitches are tenuous in the long term because they do notnecessarily penetrate the serosa. Even if the stitches penetrate theserosa, they tend to erode through the wall with time because of theirthin profile and an inability of the endoscopic operator to controltension on the suture when it is placed. With the methods and devices ofthis invention, such an endoscopic suture can be buttressed with apercutaneously placed fastener.

Other Uses for the Disclosed Devices, Instruments, and Methods

Although the described methods are focused on the implantation oftransgastric fastening assemblies to reduce the volume of the stomach,the methods and devices can easily be expanded to the percutaneousplacement of other types of devices such as neurostimulators, gastricmuscle stimulators, gastric balloons, bulking devices inside the wall ofa gastrointestinal organ, devices placed in the lesser peritoneal sacalong the autonomic nerve plexus, along the vagus nerve, on parts of thediaphragm, or placed on or along the pancreas.

In some embodiments, other devices are implanted using the describedmethods to place devices inside or outside the stomach; inside oroutside the lesser sac of the peritoneum; inside or beside a structurewithin the retroperitoneum; inside, beside, or outside the duodenum,pylorus, or gastroesophageal junction. Implanted devices include but arenot limited to the anchor devices and transgastric fastening assembliesdescribed above, neuromodulators, direct muscle stimulators, stents,meshes, stent-grafts, stitches, and bulk forming agents.

In one such embodiment, a transgastric fastening assembly serves toreduce the volume of the stomach as well as provide for electricalstimulation. In this embodiment, an electrical signal runs throughelectrodes in the transgastric fastener assembly to alter thecontraction patterns of the stomach or to electrically stimulate afeeling of satiety as well as reduce the volume of the stomach. Thus,fastener assemblies of the present invention can become electrodes whichare useful, for example, for gastric electrical stimulation. Methods anddevices of this invention can also be used to place sutures in thestomach or pylorus to treat reflux disease. Such suturing would befacilitated by the placement of multiple ports through the walls of thestomach; this would be highly beneficial over current fully endoscopicmethods of placing sutures. Any of these methods and devices could beused in combination with or in place of the transgastric fasteningassemblies to induce weight loss in a patient.

In other embodiments, the novel methods, implantation devices, andfasteners of this invention are used to implant devices in one wall of agastrointestinal organ without volume reduction. In one example of suchan embodiment, illustrated in FIGS. 10A and 10B, a balloon-like deviceis deployed in the stomach to displace volume rather than to reducevolume from the outside. The balloon 430 is the equivalent of theposterior anchors in the above embodiments, In this embodiment, afterinitial insufflation of the stomach and placement of a laparoscopic port306 in the abdominal wall 304, an instrument is used to penetrate onlythe anterior wall of the stomach 302 and place an inflatableintragastric balloon 430. Inflation is achieved through connector 432and the balloon is placed within the interior of the stomach 428, asillustrated in FIG. 10A. When inflated, the balloon 430 is preferablyspherical in shape such that it occupies a portion of the stomach volumewhen inflated. In the embodiment shown, the connector also acts as theinflation tube for inflating the intragastric balloon. In anotherembodiment, there is a separate inflation tube in addition to theconnector. As discussed above, a valve can be located between the anchorand the connector, or alternatively outside the patient. Preferablyafter the intragastric balloon is inflated, an anterior anchor 434.isdeployed on the connector 432 as described previously, the connector iscut, preferably flush with the anterior anchor, and the laparoscopicport is removed, as shown in FIG. 10B. In the preferred embodiment wherean inflatable anterior anchor 434 is used, the inflation tube is alsocut, preferably flush with the anterior anchor.

Alternative Implantation Techniques

Although the methods described in this disclosure focus on apercutaneous surgical procedure where general anesthesia and paralysisare not used, it is conceivable that the surgeon may want to use generalanesthesia and paralysis. Such may be the case when the adhesions behindthe stomach are severe and it will be safer to perform a standardlaparoscopic procedure to implant the devices of this invention. In sucha case, the percutaneous instruments and implants described in thisinvention will be used, but the surgeon will additionally have theadvantage of laparoscopic instrumentation and tools which can free theposterior gastric wall from the retroperitoneum under directvisualization.

It is also possible that a part of, or the entire procedure is performedunder for example with a fluoroscope, MRI, CAT scan, or ultrasound, inwhich the structures behind the stomach are can be visualized.

Although the present invention has been described in the context ofcertain preferred or illustrative embodiments, it should be understoodthat the scope of the exclusive right granted by this patent is notlimited to those embodiments, but instead is the fill lawful scope ofthe appended claims.

1. A device for compressing a least one region of an anatomicalstructure comprising: a first anchor configured to communicate force tothe anatomical structure from outside of the anatomical structure; asecond anchor configured to communicate force to the anatomic structure;and a connector which links said first and said second anchors.
 2. Adevice for modifying a lumenal structure in a human subject comprising:at least one first anchor capable of communicating force to ananatomical region outside of the lumenal structure; at least one secondanchor capable of communicating force to the inner surface of thelumenal structure; and a tethering element capable of linking the firstand second anchors.
 3. A system for altering the cross-section of alumenal structure within the body of a human subject comprising: anintroducer device positionable inside the lumenal structure; and adevice that is introduceable through the introducer device into thelumenal structure, said device being configured to apply force to theluminal structure from outside the luminal structure.
 4. A system fortreating a condition in a human patient by modifying the tissue or theflow in the anatomical structure in the body of the human, causes achange in the human condition, said system comprising: an anchor devicecomprising a first anchor, a second anchor; and a connector that extendsbetween said first and said second anchors.
 5. The system of claim 4wherein at least one of said first and said second anchors comprises agripping element.
 6. The system of claim 4, wherein at least one of saidfirst and said second anchors comprises a T shaped anchor.
 7. The systemof claim 4, wherein at least one of said first and said second anchorscomprises a fabric, textile, or other porous material.
 8. The system ofclaim 4, wherein at least one of said first and said second anchors hasa deployed and an undeployed configuration and is constructed to receivea surroundin lumenal device during insertion of the anchor.
 9. Thesystem of claim 4, wherein at least one of said first and said secondanchors comprises a mesh material.
 10. The system of claim 4, wherein aleast one of said first and said second anchors is configured to engageor rest on a surface of a lumenal structure within said human subject.11. The system of claim 4, wherein said connector comprises a suture.12. The system of claim 4, wherein said connector can be shortened afterat least one of said anchors has been implanted.
 13. The system of claim4, further comprising a delivery device for delivering said anchordevice into the human subject's body.
 14. The system of claim 13,wherein the delivery device comprises an elongate member having a lumen;wherein said anchor device is initially contained within the lumen ofsaid elongate member; and wherein said anchor device is moveable throughthe lumen and thence out of the lumen.
 15. The system of claim 14,wherein said elongate member is configured to be advanced into a lumenalstructure in said human subject, and then into an anatomical structureadjacent to said lumenal structure.
 16. The device of claim 1, whereinsaid anatomical structure is a stomach.
 17. The device of claim 4,wherein said anatomical structure is a stomach.
 18. The device of claim13, wherein said anatomical structure is a stomach.
 19. A kit formodifying the volume of an internal organ of a patient comprising: afirst anchor, a second anchor, and a connector; wherein at least one ofsaid first or said second anchors have a deployed configuration; whereinsaid first anchor and said second anchor each have a surface areasufficient to prevent said first anchor and said second anchor frompassing through said organ or tissue when in said deployedconfiguration; and wherein said connector and said anchors areconfigured to permit said first anchor and said second anchor to belinked through said connector.
 20. The kit of claim 19, wherein at leastone of said first and said second anchors has an undeployedconfiguration wherein a profile of said undeployed configuration isreduced compared to said profile of said deployed configuration.
 21. Thekit of claim: 19, wherein at least one of said first and said secondanchors is configured to be deployed in said patient prior to beingconnected to said connector.
 22. The kit of claim 19, wherein at leastone of said first and said second anchors is configured to be deployedon a surface of said organ or tissue.
 23. The kit of claim 19, whereinsaid connector comprises a monofilament.
 24. The kit of claim 19,wherein said connector comprises a multifilament.
 25. The kit of claim19, wherein said connector comprises an elongate portion having at leastone toothed surface.
 26. The kit of claim 19, wherein said connector iselastic.
 27. The kit of claim 19, wherein said connector is configuredto permit said connector to be shortened after at least one of saidfirst and said second anchors has been implanted.
 28. The kit of claim19, further comprising a tensioning instrument configured to urge saidfirst and said second anchor close together when said connector isconnected to said first and said second anchors.